Ocsaar and CYP2C9 Ploymorphism, Is There a Connection Between Pharmacokinetics, Pharmacodynamics and Pharmacogenetics?
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ClinicalTrials.gov Identifier: NCT00732966 |
Recruitment Status : Unknown
Verified August 2008 by Assaf-Harofeh Medical Center.
Recruitment status was: Not yet recruiting
First Posted : August 12, 2008
Last Update Posted : August 12, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: losartan Drug: valsartan | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | Ocsaar and CYP2C9 Ploymorphism, Is There a Connection Between Pharmacokinetics, Pharmacodynamics and Pharmacogenetics? |
Study Start Date : | September 2008 |
Estimated Primary Completion Date : | September 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Hypertensive patients will be treated with losartan for one months
|
Drug: losartan
with losartan 50 mg once daily for one month Drug: valsartan valsartan 160 mg once daily |
Experimental: 2
Hypertensive patients will be treated with valsartan
|
Drug: losartan
with losartan 50 mg once daily for one month Drug: valsartan valsartan 160 mg once daily |
- Blood pressure lowering effect of losartan and valsartan in patients with different CYP2C9 allels [ Time Frame: one month ]
- losartan/E-3174 ratio in different allelic groups of CYP2C9 [ Time Frame: one month ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The study will include 30 patients with the 3 most prevalent alleles of CYP2C9 *1, *2 and*3, 10 patients of each group.
Exclusion Criteria:
- Patients treated with losartan or valsartan prior to their enrollment to the study,
- Patients with BP below 140 systolic or 90 diastolic in an ambulatory 24 hours BP monitoring, acute coronary syndrome during the 6 months previous to the study,
- Renal failure with creatinin levels above 1.5 mg/dL, hyperkalemia (K > 5 mg/dL),
- Hematologic or solid malignancies or pregnancy.
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Patients will also be excluded from the study if they are known to use one of the drugs inducing or inhibiting the CYP2C9, such as
- rifampicin carbamazepine,
- ethanol,
- phenobarbitone,
- fluconazole,
- amiodarone,
- trimethoprim,
- fluvastatin,
- cimetidine
- chloramphenicol.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732966
Contact: Ronit Koren Peleg, MD | 972-524-535024 | ronitkoren@gmail.com | |
Contact: Ahuva Golik, Prof | 972-577-345242 | golik@asaf.health.gov.il |
Principal Investigator: | Ronit Koren Peleg, MD | Department of Internal Medicine A , Research & Development unit Assaf Harofeh Medical Center, Zerifin, affiliated to Sackler School of Medicine, Tel Aviv, Israel |
Responsible Party: | Koren Peleg Ronit MD, Assaf-Harofeh Medical Center internal medicine A |
ClinicalTrials.gov Identifier: | NCT00732966 |
Other Study ID Numbers: |
ronit3 |
First Posted: | August 12, 2008 Key Record Dates |
Last Update Posted: | August 12, 2008 |
Last Verified: | August 2008 |
cyp2c9 losartan pharmacogenetics pharmacokinetics pharmacodynamics |
Hypertension Vascular Diseases Cardiovascular Diseases Losartan Valsartan |
Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents |